Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML

PHASE3CompletedINTERVENTIONAL
Enrollment

711

Participants

Timeline

Start Date

December 17, 2010

Primary Completion Date

September 26, 2014

Study Completion Date

March 1, 2017

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

vosaroxin + cytarabine

"Vosaroxin days 1 and 4: 90 mg/m2 for induction 1; 70 mg/m2 for all other cycles~Cytarabine 1 g/m2 daily on days 1-5 (IDAC)"

DRUG

placebo + cytarabine

"Placebo days 1 and 4: volume matched to vosaroxin~Cytarabine 1 g/m2 daily on days 1-5 (IDAC)"

Trial Locations (124)

1023

Haematology Research, Auckland District Health Board, Auckland City Hospital, Grafton

1090

AKH Wien / MedUniWien Universtatsklinik fur Innere Medizin 1, Vienna

1200

Cliniques Universitaires Saint Luc, Brussels

2020

ZNA Middleheim Lindendreef 1, Antwerp

2139

Concord Repatriation General Hospital, Concord

2145

Westmead Hospital, Westmead

2250

Haematology Department, Gosford Hospital, Gosford

2605

The Canberra Hospital, Garran

3004

The Alfred Hospital, Melbourne

3050

Department of Clinical Haematology and BMT Service, Royal Melbourne Hospital, Parkville

3220

Andrew Love Cancer Center, Geelong Hospital, Barwon Health, Geelong

3240

Department of Haematology, Waikato Hospital, Hamilton

4029

Royal Brisbane and Women's Hospital, Brisbane

4414

Regional Cancer Treatment Service, Palmerston North Hospital, Palmerston North

5000

Haematology and Bone Marrow Transplant Unit, Royal Adelaide Hospital, Adelaide

5020

Landeskrankenhaus Salzburg, Universitaetsklinik fur innere Medizin lll, Universitaetsklinikum der PMU, Salzburg

5042

Flinders Medical Centre, Bedford Park

6000

Royal Perth Hospital, Perth

6020

University Hospital for Internal Medicine V, Innsbruck Medical University, Innsbruck

8000

AZ St.-Jan Brugge-Oostende AV, Bruges

8011

Canterbury Health Laboratories, Christchurch

8036

Universitatsklinik Graz, Universitatsklinik fur Innere Medizin, Abteilung fur Hamatologie, Graz

8800

H.-Hartziekenhuis Roeselare - Menen vzw, Roeselare

10065

Weill Cornell Medical College, New York

10595

New York Medical College, Division of Oncology/Hematology, Valhalla

11042

North Shore Long Island Jewish Health System, Lake Success

11794

Stony Brook University Medical Center, Stony Brook

13009

Institut Paoli Calmettes, Marseille

16132

Ospedaliera Universitaria San Martino di Genova, Genova

20037

George Washington University-Medical Faculty Associates, Washington D.C.

20246

Universitatsklinikum Hamburg-Eppendorf; ll. Medizinische Klinik und Poliklinik; Onkologie, Hamatologie und Knochenmarktransplantation, Hamburg

24116

Staedtisches Krankenhaus Kiel GmbH, Infektionsambulanz der 2. Medizinischen Klinik, Kiel

26506

Department of Medicine Section of Hematology/Oncology, West Virginia University Hospitals, Mary Babb Randolph Cancer Center, West Virginia University, Morgantown

27100

Fondazione IRCCS, Policlinico S. Matteo - Dipartimento di Ematologia, Pavia

27157

Wake Forest University Health Sciences, Winston-Salem

27710

Duke University Medical Center, Durham

28033

Centro Oncologico MD Anderson International Espana, Madrid

28046

Hospital Universitario La Paz, Madrid

28100

Azienda Ospedaliero-Universitaria Maggiore Della Carita, Struttura Complessa Direzione Universitaria Ematologia, Novara

28204

Mecklenburg Medical Group, Charlotte

29425

Medical University of South Carolina, Charleston

30625

Medizinische Hochschule Hannover, Abteilung Hamatologie, Hanover

30912

Georgia Health Sciences University, Augusta

31059

Service d'hematologie- Hopital Purpan- CHU de Toulouse, Toulouse

32207

Baptist Cancer Institute, Jacksonville

33308

Holy Cross Hospital, Fort Lauderdale

33604

CHU de Bordeaux- Hopital Haut-Leveque, Centre Francois Magendle, Pessac

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

37007

Hospital Universitario de Salamanca, Salamanca

37203

Tennessee Oncology, PLLC, Nashville

37232

Henry-Joyce Cancer Clinic, Nashville

38119

Family Cancer Center, Memphis

44093

CHU Nantes Hotel Dieu, Service d'hematologie clinique, Nantes

44106

University Hospitals fo Cleveland, Cleveland

44121

Azienda Ospedaliero-Universitaria Sant'Anna, Sezione di Ematologia, Dipartmento di Science Biomediche e Terapie Avanzate, Ferrara

46026

Hospital Universitari Politecnic la Fe Hematology Department, Valencia

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

46237

St. Francis Medical Group Oncology and Hematology Specialists, Indianapolis

47166

St. Johannes-Hospital, Duisburg

48109

University of Michigan, Ann Arbor

48149

University Hospital of Muenster, Münster

48202

Henry Ford Health System, Detroit

49033

CHU Angers, Service des maladies du sang, Angers

52242

University of Iowa Hospitals and Clinics, Iowa City

59037

CHU Lille, Service des maladies du sang, Hopital Huriez, Lille

60612

Rush University Medical Center, Division of Hematology/Oncology, Chicago

60637

University of Chicago, Chicago

65203

Ellis Fischel Cancer Center, University of Missouri Health Care, Columbia

65929

Klinikum Frankfurt am Main-Hochst, Department of Hematology and Oncology, Klinikum Frankfurt Academic Hospital of the University of Frankfurt, Frankfurt

69495

Centre Hospitalier Lyon Sud - Service d'Hematologie - Pavillon Marcel Berard - Bat. 1G - 1er etage, 165 Chemin du grand Revoyet, Pierre-Bénite

70121

Ochsner Clinic Foundation, New Orleans

72100

"Ospedale A. Perrino, U.O. Compessa di Ematologia", Brindisi

73100

"Ospedale Vito Fazzi, U.O Ematologia", Lecce

74078

SLK-Kliniken Heilbronn GmbH, Medizinische Klinik, Heilbronn

75390

UT Southwestern Medical Center at Dallas, Dallas

77030

The University of Texas, M.D. Anderson Cancer Center, Department of Leukemia, Houston

78157

Hopital Mignot, Le Chesnay

78229

Cancer Care Centers of South Texas, San Antonio

80131

"AORN A. Cardarelli, U.O.S.C. Ematologia con TMO", Napoli

80218

HCA HealthONE - Rocky Mountain Blood and Marrow Transplant Program, Denver

81675

Klinikum rechts der Isar der Technischen Universitat Munchen lll, Medizinische Klinik, Munich

90095

UCLA Division of Hematology/Oncology, Los Angeles

92093

Moores UCSD Cancer Center, La Jolla

92123

Sharp Clinical Oncology Research, San Diego

93000

Hopital Avicenne- Departement Onco-hematologie, Bobigny

94143

University of California San Francisco, San Francisco

100065

Memorial Sloan-Kettering Cancer Center, New York

03756

Dartmouth-Hitchcock Medical Center, Lebanon

07601

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

Unknown

ZNA Stuivenberg, Lange Beeldekensstraat 267, Antwerp

Hospital del Mar, Barcelona

B 3000

UZ Leuven, campus Gasthuisberg, Department of Haematology, Leuven

V5Z 1M9

Division of Hematology, Vancouver General Hospital, Vancouver

E2L 4L2

Saint John Regional Hospital, Saint John

B3H 2Y9

Queen Elizabeth II Health Sciences Centre, Halifax

M5G 2M9

University Health Network, Princess Margaret Hospital, Toronto

J4V 2H1

Charles LeMoyne Hospital, Greenfield Park

100 34 Praha 10

Fakultni nemocnice Kralovske Vinohrady, Oddeleni klinicke hematologie, Prague

625 00

Fakultni nemocnice Brno, Interni hematoonkologicka klinika, Brno

500 05

Fakultni nemocnice Hradec Kralove, 2. Interni klinika-oddeleni klinicke hematologie, Hradec Králové

04129

Klinikum St. Georg gGmbH; Klinik fur Internistische Onkologie/Hamatologie, Leipzig

H-4030

University of Debrecen Medical and Health Sciences Center, Debrecen

H-9024

Petz Aladar County Hospital, Győr

H-7400

kaposi Mor Oktato Korhaz Belgyogyaszati Osztaly, Kaposvár

H-6720

Szegedi Tudomanyegyetem, 11. Belgyogyaszati Klinika, Szeged

80-952

Uniwersyteckle Centrum Kliniczne, Gdansk

60-569

Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego, Szpital Kliniczny Przemiemienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan

50-369

Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu, Wroclaw

110-744

Seoul National University Hospital, Seoul

135-710

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul

137-701

Seoul St. Mary's Hospital, Seoul

138-736

Dept. of Hematology, Asan Medical Center, Seoul

08025

Hospital de la Santa Creu i Sant Pau, Barcelona

08035

Hospital Universitario Vall d'Hebron, Barcelona

08916

Hospital Universitari Germans Trias i Pujol, Barcelona

07198

Hospital Sont Llatzer, Palma de Mallorca

FY3 8NR

Blackpool Victoria Hospital, Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Cambridge

CF14 4XW

Department of Haematology, University Hospital of Wales, Cardiff

GY16 5JQ

Queen's Centre for Oncology and Hematology, Castle Hill Hospital, Cottingham

LE1 5WW

Leicester Royal Infirmary, University Hospitals of Leicester, NHS Trust, Leicester

L7 8XP

Department of Haematology, Royal Liverpool University Hospital, Liverpool

SE1 9RT

Department of Haematology, Guy's Hospital, London

M13 9WL

Central Manchester University Hospitals NHS Trust, Manchester Royal Infirmary, Manchester

Sponsors
All Listed Sponsors
lead

Sunesis Pharmaceuticals

INDUSTRY